Drug Withdrawn - Vioxx, A Perspective After National Arthritis Meeting
Vioxx (rofecoxib), a drug that has been used to quiet inflammation of arthritis and relieve pain, was withdrawn from the market by its maker, Merck, on September 30, 2004. The reason for the withdrawal was the occurrence of side effects noted in a study that Merck was conducting to see if Vioxx could prevent polyps of the colon and rectum. During this trial, it was noted that there was an increased risk for heart attack and stroke in patients continuing to take Vioxx longer than 18 months.
Below, the Medical Editor-in-Chief of MedicineNet.com, an arthritis specialist, gives a perspective on the withdrawal of Vioxx after attending the national arthritis meeting of the American College of Rheumatology October 16-21, 2004.
Dr. Shiel's Perspective: Vioxx is no longer available for use and those taking it should contact their physicians to consider alternative treatment. The risk of heart attack or stroke was small, but real. It is of note that there was no increased risk of stroke in patients taking Vioxx less than 18 months in the study. There has been no indication that any long term damage occurs once the drug is discontinued.
The question of interest is a natural concern for inflammation medications of the same class as Vioxx. This class is referred to as Cox-2 inhibitors and includes Celebrex (celecoxib) and Bextra (valdecoxib) NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the FDA press release. . At the national meeting, an FDA spokesperson commented that there is currently an ongoing trial of Celebrex in the prevention of colon polyps. The FDA asked that the 5 year study (now at 2 years) be opened to see if there were signs that Celebrex was increasing the risk of heart attacks or stroke in the study patients. The FDA has allowed the study to continue after reviewing the preliminary data. It therefore seems that not all Cox-2 antiinflammatory drugs are the same. The FDA spokesperson stated that there is no definitive evidence that Celebrex carries an increased risk for heart disease or stroke. It may be, in fact, that different Cox-2 drugs, having different powers of selective action on the Cox-2 enzyme, may have different potential for these blood vessel risks. More data will be forthcoming that will help to clarify risks of drugs used to treat inflammation.
Interestingly, Merck has a drug now on the market outside of the U.S. that is used for pain and inflammation relief. The drug, etoricoxib (Arcoxia) was presented in 4 studies at the national meeting and shown to be safe and effective in treating gout, osteoarthritis, and ankylosing spondylitis. Etoricoxib (Arcoxia) is awaiting approval for use in the U.S. and while its maker notes that it has been shown to be safe, I believe it will undergo serious scrutiny of longer term studies prior to approval for the U.S. market.
Last Editorial Review: 4/7/2005
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